Overview

This trial is active, not recruiting.

Conditions gastrointestinal stromal tumor, metastatic cancer
Treatment therapeutic conventional surgery
Phase phase 2
Sponsor Niigata University Medical and Dental Hospital
Start date October 2008
End date September 2014
Trial size 44 participants
Trial identifier NCT00769782, CDR0000615624, NIIGATAU-TRIGIST0804

Summary

RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor.

PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Recurrence-free survival
time frame:

Secondary Outcomes

Measure
Overall survival
time frame:
Microscopically complete resection rate (R0 resection)
time frame:
Postoperative morbidity and mortality
time frame:

Eligibility Criteria

Male or female participants at least 20 years old.

DISEASE CHARACTERISTICS: - Diagnosis of gastrointestinal stromal tumor (GIST) - Hepatic metastasis meeting the following criteria: - Clinically diagnosed as surgically resectable with no macroscopic residual tumor - No more than 3 hepatic metastases - Synchronous hepatic metastasis allowed provided primary tumor is also resectable - Does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease - No extrahepatic metastasis - No history of GIST recurrence PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Leukocyte count ≥ 3,000/μL - Neutrophil count ≥ 1,500/μL - Hemoglobin ≥ 8.0 g/dL - Platelet count ≥ 75,000/μL - Total bilirubin ≤ 2.0 mg/dL - ALT and AST < 120 IU/L - GTP < 210 IU/L - Not pregnant - No poorly controlled diabetes mellitus - No NYHA class III-IV cardiac function - No hepatitis B or hepatitis B carriers - No other malignancy requiring treatment PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior interventional radiology for metastatic disease - No prior or concurrent imatinib mesylate - No other concurrent treatment

Additional Information

Official title Phase II Multicenter Clinical Trial on Surgery for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
Principal investigator Tatsuo Kanda, MD
Description OBJECTIVES: - To evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor. OUTLINE: This is a multicenter study. Patients undergo surgical resection of hepatic metastasis.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).